Management Of Shortages Research Articles

Drug Shortages: A Scoring System to Evaluate and Prioritize the Clinical Importance of Drugs in Canada

Drug shortages are an ongoing global health issue and pose significant challenges to policy-makers and health care providers. They may result from various factors (e.g., supply chain disruptions and recalls) and have a negative impact on patient outcomes and health care expenditures. The ability to accurately predict drugs at risk of a shortage would be a vital aspect in the effective management of drug shortages and help ensure proactive measures for consistent drug supply and optimized patient care; however, these drugs must also be prioritized in a meaningful way to identify high priority targets among the large number of drugs in the market and help ensure resources are allocated to the most important at-risk drugs. The purpose of this Environmental Scan aimed to identify a systematic method of objectively evaluating and ranking the value of drugs based on important clinical criteria and adapt the selected tool to prioritize the clinical importance of drugs in Canada. A total of 5 potential scoring systems were considered, and 1 scoring system was selected and adapted (based on expert panel member feedback). Finally, an assessment of 9 clinical criteria was made across 5 broad categories. The criteria include an evaluation of disease severity, size of the population, clinical guidelines, comparator interventions limitations (unmet needs), improvement of efficacy or effectiveness, improvement of safety and tolerability, improvement of patient-reported outcomes (PRO), type of medical service (e.g., symptom relief, prolonging life, cure), and public health interest. The proposed tool can be used in situations where decision-making requires an objective and systematic evaluation of drugs' clinical importance. Additionally, it will help inform a drug shortage risk framework in Canada, which will consider both the clinical importance and supply chain risks of drugs as part of the Health Canada Drug Shortages Task Force.

Comparing visual inspection methods for parenteral products in hospital pharmacy: between reliability, cost, and operator formation considerations

IntroductionThe COVID-19 pandemic has led to unforeseen and novel manifestations, as illustrated by the management of drug shortages through the development of hospital production of sterile pharmaceutical preparations (P2S). Visual...

Managing disrupted supply chains in Swedish hospitals during the COVID-19 pandemic

ABSTRACT The COVID-19 pandemic has disrupted global supply chains and caused widespread shortages of healthcare supplies. This mixed-methods study examined the management of supply shortages in Swedish hospitals during the COVID-19 pandemic. The key findings are that the shortage of supplies was initially severe owing to low regional and national contingency inventory levels, a lack of knowledge of supply chain management, and cost-saving measures. The perceived consequences of the shortage of personal protective equipment persisted in emergency and inpatient departments, in the later waves. Although pharmaceutical shortages later decreased, hospital managers were disappointed that they persisted. This study also highlights the effectiveness of consensus-based hourly supply agreements between service organisations and unit managers, which makes the prioritisation of the limited supply more dynamic. Despite these challenges, hospitals were able to adapt to the supply chain disruptions caused by the pandemic; however, the results emphasise the importance of preparedness for future pandemics.

Shortages of clinical nutritional components and management strategies

Parenteral nutrition (PN) solution is a medication of high concern due to its intricate drug utilization procedure. It has been reported that since 2010, nearly every component involved in the preparation of PN admixtures has experienced a shortage at least once. Shortages may lead to therapy delays in hospitals, clinics and other health-related facilities or reductions in quality, prompting healthcare providers to recommend alternative treatments, potentially leading to medication errors, negatively influencing patient outcomes, and consume healthcare assets. The causes of medication shortages are diverse and encompass unidentified factors (44%), manufacturing complications (36%), supply and demand imbalances (8%), discontinued product lines (8%), insufficient access to raw materials (4%), and natural disasters. The duration for the resolution of these shortages was inconsistent, with certain product shortages that were resolved experiencing a recurrence, while others persisted for several months to years. The pharmacy department can take the lead in efficiently managing drug shortages by guaranteeing that its institution possesses the essential infrastructure and a clearly outlined management strategy well in advance of any shortages arising. During periods of shortages, it is extremely important to limit the use of nutritional products to patients with valid indications and those with nonfunctional gastrointestinal systems. Effective management of drug shortages, including PN components, necessitates a comprehensive plan and the involvement of an interprofessional team. This team should contribute to the development of the plan and be ready to implement it swiftly in case of a shortage or outage. Once the shortage of PN components is deemed resolved, all rationing and conservation strategies should be halted, as these measures are meant to be employed exclusively during shortages. Once the PN component shortage has been resolved, it is crucial to resume providing the full dosage of PN components to all patients in need of PN therapy.

ASCO Ethical Guidance for the Practical Management of Oncology Drug Shortages.

ASCO Ethical Guidance for the Practical Management of Oncology Drug Shortages.

Exploring the Experiences of Pharmacists with Drug Shortages in the UK

Abstract Introduction Drugs can become short in supply for many reasons including increased demand and reduced production1. Drug shortages have the potential to impact patients and pharmacists. A recent study reported pharmacists spending up to 11 hours per week dealing with drug shortages2. However, the overall impact of experiencing and dealing with drug shortages on pharmacists and patients has not been fully investigated, particularly within community pharmacy, an area of practice that has been struggling with drug shortages. Aim To highlight the challenges pharmacists face and the constraints within the current system when dealing with drug shortages. Methods The study was reviewed and received ethical approval. This was a survey study involving practising community pharmacists in the UK. Pharmacists were invited through social media and professional networks to complete a validated online survey during the period of September to December 2021. Survey data was analysed using descriptive statistics. Results 100 responses were received from 11 regions in the UK. Eighty three percent of the respondents were experiencing drug shortages 3 or more times per week and more than 70% spent 1-3 hours per week dealing with them. The majority of the respondents (93%, n = 93) indicated that drug shortages were a problem for them and sixty one (n = 100) respondents reported that they had worsened since the start of the pandemic. In addition, sixty five (n = 100) respondents believed that drug shortages had had an impact on patient care. How the respondents dealt with prescriptions for drugs that were in shortage varied with a third (34%) responding they would contact the prescriber and suggest an alternative. The respondents suggested ways for improving the management of drug shortages including giving pharmacists more legal power to change prescriptions, increasing the number of Serious Shortage Protocols (SSPs) and providing early and transparent communications. Discussion/Conclusion Spending time dealing with drug shortages impacts on the pharmacists’ workloads and quality of patient care. There was a variation between how respondents indicated they dealt with drug shortages. Patients should be able to obtain their medicine(s) and pharmacists need to respond in a way that ensures delivery of person-centred care. How pharmacists deal with shortages and why they do this needs further exploration. Some respondents suggested ways to help manage drug shortages. An increase in number of SSP’s may not be the best approach as they can be inflexible and time consuming. Initiatives such as more legal powers have received attention by the Royal Pharmaceutical Society (RPS) who believes an amendment in law to allow pharmacists to make minor changes to prescriptions affected by drug shortages would improve patient access to medicines and reduce the burden on the healthcare system. This comes at a time when community pharmacists are under pressure to offer services such as minor ailments, blood pressure checks and contraception. Despite the survey being undertaken over a year ago and the small sample size, drug shortages continue to be an issue that impacts community pharmacists, which requires further investigation.

Prevention and management of health products shortages by the French national agency (ANSM), 10 years of experience.

Shortages of drugs and medical devices have tended to increase in France and worldwide, with consequences for patients and healthcare professionals. Preventing shortages of health products has become a priority for regulatory authorities, including the French National Agency for Medicines and Health Products Safety (ANSM). To highlight perspectives for a better prevention, we described and analyzed the management of shortages in the availability of health products in France over the last 10 years. The supply chain was mapped to identify the main causes of shortages and stakeholders involved in managing shortages throughout the supply chain. National and European initiatives and regulatory measures were reviewed. A retrospective nationwide data analysis from the French reporting system of health product shortage reports was conducted over 10 years for drugs (2013-2022) and over an 18-month period for medical devices, from 1st March 2022 to 31st August 2023. An increase in drug shortage reports was observed, rising from 404 in 2013 to 3,761 in 2022 for drugs, with a relatively constant distribution of affected therapeutic classes. In 2022, the main reported causes of drug shortage risk were insufficient production capacity (27.1%), increased sales volume (21.5%), or lack of supply (13.6%). Over half of the reports on medical devices (55.4%) were objectified as indispensable, and their causes were mainly due to a lack of supply (48.2%), discontinuation of marketing (14.9%), increased sales volume (13.2%), and regulatory reasons (9.6%). ANSM and French authorities have engaged a public health policy for prevention and management of health product shortages including financial penalties, minimum safety stocks for Major Therapeutic Interest drugs, and a shortage management plan. Based on 10 years of experience, four priority measures have been identified to anticipate the risk of heath products shortages based: the importance of a national coordination from raw materials to local market, the implementation of new prevention and management actions in the supply chain, strengthening European cooperation and regulation including the establishment of a list of critical drugs, and promoting transparency and information.

Development and validation of the nomogram to predict the risk of hospital drug shortages: A prediction model.

Reasons for drug shortages are multi-factorial, and patients are greatly injured. So we needed to reduce the frequency and risk of drug shortages in hospitals. At present, the risk of drug shortages in medical institutions rarely used prediction models. To this end, we attempted to proactively predict the risk of drug shortages in hospital drug procurement to make further decisions or implement interventions. The aim of this study is to establish a nomogram to show the risk of drug shortages. We collated data obtained using the centralized procurement platform of Hebei Province and defined independent and dependent variables to be included in the model. The data were divided into a training set and a validation set according to 7:3. Univariate and multivariate logistic regression were used to determine independent risk factors, and discrimination (using the receiver operating characteristic curve), calibration (Hosmer-Lemeshow test), and decision curve analysis were validated. As a result, volume-based procurement, therapeutic class, dosage form, distribution firm, take orders, order date, and unit price were regarded as independent risk factors for drug shortages. In the training (AUC = 0.707) and validation (AUC = 0.688) sets, the nomogram exhibited a sufficient level of discrimination. The model can predict the risk of drug shortages in the hospital drug purchase process. The application of this model will help optimize the management of drug shortages in hospitals.

Les ruptures de médicaments vétérinaires

Veterinary drugs shortages can have serious consequences and increase veterinary drug availability problems. These shortages affect all categories of drugs and in all species, even if sterile products (and in particular vaccines) remain the most affected pharmaceutical form. Arround 80 notifications of rupture are made per year and about fifteen are deemed critical, i.e. likely to have an impact on animal health. The main origins of these shortages are problem of production, raw material supply or quality problems… These problems are difficult to predict and eli-minate completely. In order to better manage the consequences of shortages, the ANMV (the french national competent authority) and professionals have put in place a best practice guide for the management of shortages based on a good circulation of information with the aim of anticipation. The ANMV can thus study alternative solutions and implement them when they exist. The development at European level of a group dedicated to this problem facilitates the search for solutions and a harmonized European approach.

Part I: Interactive case: Management of urgent drug shortages

JACCP: JOURNAL OF THE AMERICAN COLLEGE OF CLINICAL PHARMACYVolume 5, Issue 12 p. 1328-1331 PSAP IN JACCP Part I: Interactive case: Management of urgent drug shortages Milena Murray Pharm.D., FCCP., Milena Murray Pharm.D., FCCP. orcid.org/0000-0002-8748-185X Search for more papers by this author Milena Murray Pharm.D., FCCP., Milena Murray Pharm.D., FCCP. orcid.org/0000-0002-8748-185X Search for more papers by this author First published: 08 December 2022 https://doi.org/10.1002/jac5.1726Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Volume5, Issue12December 2022Pages 1328-1331 RelatedInformation

Management Strategies During the COVID-19 Pandemic Crisis: The Experiences of Health Managers from Iran, Ardabil Province.

The COVID-19 outbreak is the most threatening public health challenge in the 21th century, and more than 200 countries are affected. Considering that Iran was one of the first countries influenced by the COVID-19 pandemic, this study aimed to explain the crisis management strategies during the COVID-19 pandemic in Ardabil province. This study employed a qualitative method using content analysis in which 12 healthcare managers or decision makers involved in the management of the COVID-19 crisis were recruited through purposeful sampling. In-depth, semi-structured interviews were used to collect data which continued until data saturation. Data analysis led to 9 categories, including prior preparation for the COVID-19 crisis; challenges and management of workforce shortages; benefiting from the participation of volunteer staff; challenges and strategies for physical space, supplies, and PPE; designation of referral centers for COVID-19; protocolized patient transport; benefiting from donations and charity support; management of information about COVID-19; and learning from the prior stages of crisis. This study revealed that in critical situations, managers use multiple and, to some extent, unique strategies for decision making and crisis control. Therefore, the health system can use the findings of the current study for proper response to similar crises and training of future managers.

What impact does medicines shortages have on patients? A qualitative study exploring patients\u2019 experience and views of healthcare professionals

BackgroundThe shortage of medicines represents a complex global phenomenon that triggers patient care and safety issues. The study was undertaken to explore the impact of medicines shortages on patients in Pakistan. The study also identified barriers which hinder the solutions of medicines shortages issue.MethodsA qualitative study design was adopted and the data was collected in stages between July and September 2019using an in-depth interview approach. The purposive and convenient sampling strategy was used to recruit the study participants. Sample size was limited by using the saturation point criteria. All interviews were audio-recorded, transcribed verbatim, and analyzed using thematic analysis.ResultsA total of 35 stakeholders including 13 physicians, 12 pharmacists and 10 patients participated in the study. The findings of the study were classified into five key themes and seven subthemes. The five themes included, ‘impact of medicine shortages on patients’, ‘patients’ practices in response to medicine shortages’, ‘influence of medicines shortages on medical practice or pharmaceutical business’, ‘barriers to solutions for medicines shortages’, and ‘suggestions to assuage the impact of medicine shortages.’This study showed that the medicine shortages had significant clinical and financial impact on patients. Patients’ opted for a number of risk-prone practices to avoid treatment disruption during shortages. An array of pharmaceutical market, medicines quality and patient related factors refrain physicians to switch from brand name medicine to generics and lead to ineffective management of medicines shortages. Promotion of generic prescription, implementation of punitive policies and proper patient consultation was advised to assuage the impact of medicine shortages on patients.ConclusionThe adverse clinical, economic and humanistic impact affirmed in this study demand the introduction of risk-management strategies for medicines shortages in hospital and community settings in accordance with the international standards. Promotion of effective patient counselling by the healthcare professionals to deter risk-prone practices associated with medicines shortages is mandatory.

Analysis on the Current Situation of Classified Management of Drug Shortages: Case China

Analysis on the Current Situation of Classified Management of Drug Shortages: Case China

Management of a parenteral opioid shortage using ASHP guidelines.

PurposeManagement of an acute shortage of parenteral opioid products at a large hospital through prescribing interventions and other guideline-recommended actions is described.SummaryIn early 2018, many hospitals were faced with a shortage of parenteral opioids that was predicted to last an entire year. The American Society of Health-System Pharmacists (ASHP) has published guidelines on managing drug product shortages. This article describes the application of these guidelines to manage the parenteral opioid shortage and the impact on opioid dispensing that occurred in 2018. Our approach paralleled that recommended in the ASHP guidelines. Daily dispensing reports generated from automated dispensing cabinets and from the electronic health record were used to capture dispenses of opioid medications. Opioid prescribing and utilization data were converted to morphine milligram equivalents (MME) to allow clinical leaders and hospital administrators to quickly evaluate opioid inventories and consumption. Action steps included utilization of substitute opioid therapies and conversion of opioid patient-controlled analgesia (PCA) and opioid infusions to intravenous bolus dose administration. Parenteral opioid supplies were successfully rationed so that surgical and elective procedures were not canceled or delayed. During the shortage, opioid dispensing decreased in the inpatient care areas from approximately 2.0 million MME to 1.4 million MME and in the operating rooms from 0.56 MME to 0.29 million MME. The combination of electronic health record alerts, increased utilization of intravenous acetaminophen and liposomal bupivacaine, and pharmacist interventions resulted in a 67% decline in PCA use and a 65% decline in opioid infusions.ConclusionA multidisciplinary response is necessary for effective management of drug shortages through implementation of strategies and practices for notifying clinicians of shortages and identifying optimal alternative therapies.

Overview of the causes and management of drug shortages in the United States and in Hungary

Drug shortages are a multifactorial international concern that is increasingly reported all over the world. A continuously rising number of cases could be observed since 2001, but the issue is particularly significant since 2009. In Hungary, the same increasing tendency was observed; while in 2012 464 shortages occurred, in 2020 1466 cases were reported. According to the Food and Drug Administration, there are three root causes behind the shortages, but several factors can be derived from them. This paper aims at conducting a comprehensive review of literature, exploring these factors in detail and thereby explaining how each of these factors contributes to shortages. Furthermore, it will illustrate how the lack of sufficient information due to an imperfect warning system also contributes to the issue. As the problem affects every stakeholder in the supply chain from patients to Marketing Authorisation Holders, each party should be involved in the development and implementation of mitigating strategies that can provide the basis of policy measures. The article highlights how international trends both in terms of affected therapeutic areas and causes of shortages are reflected in the Hungarian markets; therefore similar approaches could be adapted to tackle the issue domestically and deliver enduring solutions.

Rethinking the Drug Distribution and Medication Management Model: How a New York City Hospital Pharmacy Department Responded to COVID-19.

Beginning in March 2020, New York City began the fight against coronavirus disease 2019. Health care workers were faced with a disease that led to significant morbidity and mortality with no proven therapies. As hospitals became inundated with patients and underwent rapid expansion of capacity, resources such as drugs, protective and medical equipment, and hospital staff became limited. Pharmacists played a critical role in the management of clinical care and drug delivery during the pandemic. As members of the department of pharmacy within NewYork‐Presbyterian Hospital, we describe our experiences and processes to overcome challenges faced during the pandemic. Strict inventory management through the use of daily usage reports, frequent communication, and minimization of waste was critical for the management of drug shortages. The creation of guidelines, protocols, and restrictions were not only used to mitigate drug shortages, but also helped educate health care providers and guided medication use. Managing technology through setting up new automatic dispensing cabinets to address hospital expansions and modifying the electronic order entry system to include new protocols and drug shortage information were also vital. Additional key pharmacist functions included provision of investigational drug service support and training of pharmacists, prescribers, nurses, and respiratory therapists to educate and standardize medication use. Through implementation of operational and clinical processes, pharmacists managed critical drug inventory and guided patient treatment. As the pandemic continues, pharmacists will remain vital members of the multidisciplinary team dedicated to the fight against the virus.

Antimicrobial Stewardship at the Core of COVID-19 Response Efforts: Implications for Sustaining and Building Programs.

We describe traditional antimicrobial stewardship program (ASP) activities with a discussion of how these activities can be refocused in the setting of the COVID-19 pandemic. Additionally, we discuss possible adverse consequences of ASP attention diversion on COVID-19 response efforts and overall implications for future pandemic planning. We also discuss ASP in collaboration with other groups within health systems and how COVID-19 may affect these relationships long term. Despite the paucity of literature on Antimicrobial Stewardship and COVID-19, the potential contributions of ASPs during a pandemic are numerous. ASPs can develop strategies to identify patients with COVID-19-like-illness; this is particularly useful when these patients are missed at the time of health system entry. ASPs can also play a critical role in the management of potential drug shortages, developing local treatment guidelines, optimizing the use of antibiotics, and in the diagnostic stewardship of COVID-19 testing, among other roles. Importantly, it is often difficult to ascertain whether critically ill patients who are hospitalized with COVID-19 have concurrent or secondary bacterial infections—ASPs are ideally situated to help optimize antimicrobial use for these patients via a variety of mechanisms. ASPs are uniquely positioned to aid in pandemic response planning and relief efforts. ASPs are already integrated into health systems and play a key role in optimizing antimicrobial prescribing. As ASPs assist in COVID-19 response, understanding the role of ASPs in pandemic relief efforts may mitigate damage from future outbreaks.

Transfusion Thresholds for Adult Respiratory Extracorporeal Life Support: An Expert Consensus Document

Severe acute respiratory distress syndrome (ARDS) can complicate novel pandemic coronavirus disease (COVID-19). Extracorporeal life support (ECLS) represents the final possible rescue strategy. Variations in practice, combined with a paucity of rigourous guidelines, may complicate blood-product resource availability and allocation during a pandemic. We conducted a literature review around venovenous extracorporeal membrane oxygenation (VV-ECMO) transfusion practices for platelets, packed red blood cells, fresh frozen plasma, prothrombin complex concentrate, and antithrombin. Pertinent society guidelines were examined, and the practice of Canadian ECLS experts was sampled through an environmental scan. This paper represents a synthesis of these explorations, combined with input from the Canadian Cardiovascular Critical Care (CANCARE) Society, Canadian Society of Cardiac Surgeons, and the Canadian Critical Care Society. We offer a pragmatic guidance document for restrictive transfusion thresholds in nonbleeding patients on VV-ECMO, which may attenuate transfusion-related complications and simultaneously shield national blood product inventory from strain during pandemic-induced activation of the National Plan for the Management of Shortages of Labile Blood Components.

Addressing Cancer Treatment Shortages in Saudi Arabia: Results of a National Survey and Expert Panel Recommendations.

PURPOSECancer treatment shortages are complex and a persistent problem worldwide. Patients with cancer are most vulnerable to drug shortages, which provides opportunities to examine the extent of the challenge(s) facing Saudi Arabia and to provide recommendations toward mitigating the impact of cancer treatment shortages on patient outcomes.MATERIALS AND METHODSA qualitative methodologic approach was conducted in April 2019 using a validated questionnaire and structured panel discussion for data generation.RESULTSOverall, 55 responses were received from practicing oncology health care professionals (26 pharmacists and 29 physicians). The annual average number of treated patients with cancer per institution was 640 (adults [n = 400] and pediatric [n = 240]). All respondents (100%) reported that cancer treatment shortages constitute a current problem in their center, with an average of 5 (range, 1-9) per month. The panelists recognized 2 fundamental points. First, the definition of cancer drug shortages should be standardized and recognized at the national level. Second, the current system must be improved to ensure proper and efficient use of the current resources. On that basis, the panelists developed 9 recommendations for action.CONCLUSIONCancer drug shortage is a significant problem in all health centers in Saudi Arabia. This study presents challenges that should be addressed at the national level and essential consensus recommendations for a coordinated action developed by a panel of experts to tackle the current national problem of cancer treatment shortages. Implementing these recommendations will provide a blueprint for management of national drug shortages in general and cancer treatment shortages in particular.

Combating drug shortages in China: surveillance warning and practice standardization.

Like other countries, China has been experiencing drug shortages during the past years, including drugs on the National Essential Medicine List and emergency drugs. Drug shortages have raised public concerns in China and have severe impacts on all stakeholders in the supply chain, especially patients and hospitals. Recently, Chinese governments have ramped up several measures to ensure a steady supply of essential and first-aid drugs. In this commentary, we share our experiences of addressing drug shortages at Hunan Province, central China. We focus on the establishment of a provincial drug shortage monitoring center, and the Center's efforts to standardize practices on the management of drug shortages and identify therapeutic alternatives for drugs in short supply based on international best practices.